Patient interface systems

ABSTRACT

A patient interface is configured to deliver a flow of pressurized breathable gas to a patient&#39;s airways. The patient interface includes a central portion with an opening configured to deliver the pressurized breathable gas to the patient&#39;s nares. A first stabilizing portion extends from the central portion and is structured to engage an outer side of a respective one of the patient&#39;s nostrils. A second stabilizing portion is opposite the first stabilizing portion and extends from the central portion. In addition, the second stabilizing surface is structured to engage an outer side of a respective one of the patient&#39;s nostrils. The central portion, the first stabilizing portion and the second stabilizing portion cooperate to form a U-shape configured to cradle the patient&#39;s nose so that the tip of the patient&#39;s nose remains exposed when the patient interface is mounted on the patient&#39;s face.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/676,516, filed Nov. 7, 2019, which is a continuation of U.S.application Ser. No. 16/108,568, filed Aug. 22, 2018, now U.S. Pat. No.10,512,745, which is a continuation of U.S. application Ser. No.14/810,525, filed Jul. 28, 2015, now U.S. Pat. No. 10,245,404, which isa continuation of U.S. application Ser. No. 13/619,512, filed Sep. 14,2012, now U.S. Pat. No. 9,149,594, which is a divisional of U.S.application Ser. No. 12/478,537, filed Jun. 4, 2009, now U.S. Pat. No.8,291,906, which claims priority to U.S. application 61/058,659, filedJun. 4, 2008, and 61/080,847, filed Jul. 15, 2008, each incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to patient interface systems for deliveryof a flow of breathable gas to a patient. The present invention alsorelates to patient interface systems that may include adhesive(s) tosupport the patient interface in engagement with the patient and/or apatient interface positioning and/or support structure.

BACKGROUND OF THE INVENTION

The use of positive airway pressure (PAP) for the treatment of sleepdisordered breathing (SDB), such as obstructive sleep apnea (OSA), wasdisclosed in U.S. Pat. No. 4,944,310. Treatment using PAP, which may becontinuous PAP (CPAP), involves the use of a patient interface which isattached to the patient's face for the provision of the flow ofbreathable gas. PAP treatment involving the use of a patient interfacethat is sealingly attached to the wearer's face may be referred to asclosed PAP.

Mild or moderate cases of SDB may not be suitable for treatment usingclosed PAP methods. For example, patients who experience mild sleepapnea, or who may snore, may not gain a significant benefit from the useof closed PAP treatment. In addition, such patients may tend to resisttreatment as closed PAP treatment methods generally are obtrusive.

For patients that require a higher prescribed pressure for treatment ofOSA, a patient interface, e.g. a mask, that forms a seal with thepatient's airways may be required. However, the patient may findadapting to current interfaces difficult. For example, the patient mayhave difficulty sleeping in a familiar, comfortable position once themask, including the headgear and air delivery hose, are fitted to thepatient to provide the required seal. Although the mask is capable ofproviding a seal and the prescribed pressure, the patient may bereluctant to use the mask due to the problem of sleeping comfortablywhile wearing the mask. This may result in the patient abandoning thetreatment.

SUMMARY OF THE INVENTION

One aspect relates to patient interface systems for delivering a flow ofbreathable gas to a patient's airways while sealing the patient'sairways.

Another aspect relates to patient interface systems that are securableto the patient using an adhesive. Still another aspect relates to theuse of adhesive that adheres to the patient's face and the patientinterface structure that engages the patient's nose. A further aspectrelates to the use of adhesive to secure the patient interface structureto the patient and the adhesive is adhesively or mechanically connectedto the patient interface structure.

Another aspect relates to the use of adhesive to position and stabilizethe patient interface structure to deliver a flow of breathable gas.Still other aspects relate to the use of adhesive and additionalfastening arrangements, such as hook and loop fastening material,magnets, interference fittings, or electrostatic connectors, to positionand stabilize the patient interface structure. Even further aspectsrelate to additional positioning and stabilizing arrangements usablewith or without adhesive.

Yet another aspect relates to a patient interface system that includesadhesive to adhere the patient interface structure to the face of thepatient and permits the repositioning of the patient interface structurewhile the patient interface structure remains adhered to the face of thepatient.

A further aspect relates to patient interface systems that are securableto the patient using adhesive and that provide for dilation of thepatient's nasal passageways.

Still another aspect relates to a patient interface system that includesan inflatable nozzle, such as a nasal pillow, that is configured toexpand and sealingly engage the patient's nares upon the application ofa flow of breathable gas. Another aspect relates to support for thepatient interface structure including the inflatable nozzle which may besecured across the bridge of the patient's nose with adhesive.

Yet another aspect relates to patient interface structure that includesan inflatable membrane that may be connected to the inflatable nozzles.

According to a sample embodiment, a patient interface system fordelivering a flow of breathable gas to a patient comprises a patientinterface structure configured to sealingly engage the patient's nares;a pair of arms configured to be connected to opposite sides of thepatient interface structure; and adhesive configured to secure thepatient interface structure in sealing engagement with the patient'snares, wherein the adhesive is provided on the arms, and the arms areconfigured to be adhered to sides of the patient's nose by the adhesive.

Another aspect of the present technology is a two part arrangement. Afirst part is adhesively secured to the face of the patient, e.g. sidesof the nose. A second part, comprising a seal forming structure such asnasal pillows, is removably attachable to the first part. Removableattachment between the first and second parts may be achieved by a rangeof mechanisms such as adhesive and mechanical interlocking structuressuch as hook and loop material or interlocking fasteners, e.g.manufactured by 3M Corporation.

According to another sample embodiment, a patient interface system fordelivering a flow of breathable gas to a patient comprises a firstcomponent comprising adhesive on a first side and a first fastenerelement on a second side, wherein the adhesive is configured to adherethe component to the face of the patient; and a patient interfacestructure configured to sealingly engage the patient's airways, thepatient interface structure including a second component comprising asecond fastener element configured to engage the first fastener elementof the first strip to secure the patient interface structure in sealingengagement with the patient's face. The patient interface structure isrepositionable by disengaging the second component from the firstcomponent and reengaging the second component with the first component.

According to a further sample embodiment, a patient interface system fordelivering a flow of breathable gas to a patient comprises a patientinterface structure, the patient interface structure including a baseportion defining a breathing cavity configured to receive the flow ofbreathable gas through an aperture in the patient interface structure,pair of nasal pillows or prongs configured to engage the nares of thepatient to deliver the flow of breathable gas from the breathing cavityto the patient; and adhesive on the pair of nasal pillows or prongsconfigured to secure the patient interface structure to the patient.

According to a still further sample embodiment, a patient interfacesystem for delivering a flow of breathable gas to a patient comprises apatient interface structure comprising a pair of nasal prongs or pillowsconfigured to sealingly engage the patient's nares; and at least onespring configured to bias the nasal prongs or pillows outwards intoengagement with the nares of the patient.

According to yet another sample embodiment, a patient interface systemfor delivering a flow of breathable gas to a patient comprises a patientinterface support structure configured to be connected to a hose thatdelivers the flow of breathable gas; a pair of nasal pillows supportedby the patient interface support structure, wherein each nasal pillow isconfigured to inflate and seal against an interior of the patient'snares by an increase of pressure in the patient interface supportstructure from receipt of the flow of breathable gas; a support memberconfigured to engage a bridge of the patient's nose; and a connectingmember configured to connect the support member and the patientinterface support structure.

According to a further sample embodiment, a patient interface system fordelivering a flow of breathable gas to a patient comprises a patientinterface structure configured to sealingly engage the face of thepatient; and a retaining element configured for application to thepatient, said retaining element being configured to support the patientinterface structure in sealing engagement with the face of the patient,the retaining element comprising an adhesive and/or at least one strap.The patient interface structure is configured to be released from andre-engaged with the retaining element for re-positioning of the patientinterface structure relative to the patient's face in a plurality ofpositions while the retaining element remains supported by the patient

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the varioussample embodiments, wherein:

FIG. 1 schematically illustrates a patient interface structure accordingto a sample embodiment;

FIG. 2 schematically illustrates an adhesive strip connector accordingto a sample embodiment usable with the patient interface structure ofFIG. 1;

FIGS. 3a and 3b are schematic front and side views of an interfacesystem according to a sample embodiment including the patient interfacestructure of FIG. 1 and the adhesive strip connectors of FIG. 2;

FIG. 4 schematically illustrates an adhesive strip connector accordingto another sample embodiment that is usable with the patient interfacestructure of FIG. 1;

FIGS. 5-7 schematically illustrate an interface system according toanother sample embodiment;

FIGS. 8a and 8b schematically illustrate an interface system accordingto another sample embodiment;

FIG. 9 schematically illustrates an interface system according toanother sample embodiment;

FIG. 10 schematically illustrates an interface system according toanother sample embodiment;

FIGS. 11a and 11b schematically illustrate an interface system accordingto another sample embodiment;

FIG. 12 schematically illustrates an interface system according to asample embodiment;

FIGS. 13a-13f schematically illustrate an interface system according toanother sample embodiment;

FIG. 14 schematically illustrates a patient interface structureaccording to another sample embodiment;

FIG. 15 schematically illustrates an interface system according toanother sample embodiment;

FIG. 16 schematically illustrates an interface system according toanother sample embodiment;

FIGS. 17 and 18 schematically illustrate an interface system accordingto a sample embodiment;

FIG. 19 schematically illustrates an interface system according toanother sample embodiment;

FIGS. 20a and 20b schematically illustrate an interface system accordingto another sample embodiment;

FIG. 21 schematically illustrates an interface system according toanother sample embodiment;

FIGS. 22 and 23 schematically illustrate an interface system accordingto another sample embodiment;

FIGS. 24 and 25 schematically illustrate an interface system accordingto another sample embodiment;

FIG. 26 schematically illustrates an adhesive strip connector accordingto another sample embodiments;

FIGS. 27 and 28 schematically illustrate an interface system accordingto another sample embodiment of the invention;

FIG. 29 schematically illustrates a patient interface structureaccording to another sample embodiment;

FIG. 30 schematically illustrates an interface system according toanother sample embodiment;

FIG. 31 schematically illustrates an interface system according toanother sample embodiment;

FIGS. 32 and 33 schematically illustrates an interface system accordingto another sample embodiment;

FIG. 34 schematically illustrates an interface system according toanother sample embodiment;

FIG. 35 schematically illustrates an interface system according toanother sample embodiment;

FIG. 36 schematically illustrates a patient interface structureaccording to another sample embodiment;

FIG. 37 schematically illustrates an interface system according toanother sample embodiment;

FIGS. 38 and 39 schematically illustrate a patient interface structureaccording to another sample embodiment;

FIGS. 40 and 41 schematically illustrate an interface system accordingto another sample embodiment;

FIGS. 42-44 schematically illustrate an interface system according toanother sample embodiment of the invention;

FIGS. 45-47 schematically illustrate an interface system according toanother sample embodiment;

FIGS. 48 and 49 schematically illustrate an interface system accordingto another sample embodiment;

FIGS. 50a-50c schematically illustrate an interface system according toanother sample embodiment;

FIGS. 51a and 51b schematically illustrate an interface system accordingto another sample embodiment;

FIGS. 52a and 52b schematically illustrate an interface system accordingto another sample embodiment;

FIG. 53 schematically illustrates an interface system according toanother sample embodiment;

FIG. 54 schematically illustrates an interface system according toanother sample embodiment;

FIG. 55 schematically illustrates an interface system according toanother sample embodiment;

FIG. 56 schematically illustrates an interface system according toanother sample embodiment;

FIG. 57 schematically illustrates an interface system according toanother sample embodiment;

FIG. 58 schematically illustrates an interface system according toanother sample embodiment;

FIGS. 59a and 59b schematically illustrate an interface system accordingto another sample embodiment;

FIGS. 60a and 60b schematically illustrate a nasal cradle and adhesivefor positioning an interface system according to a sample embodiment;

FIG. 61 schematically illustrates an adhesive strip for positioning aninterface system according to another sample embodiment;

FIG. 62 schematically illustrates an adhesive strip for positioning aninterface system according to another sample embodiment;

FIGS. 63a and 63b schematically illustrate an adhesive strip forpositioning an interface system according to another sample embodiment;

FIG. 64 schematically illustrates an adhesive strip for positioning aninterface system according to another sample embodiment;

FIGS. 65a and 65b schematically illustrate an interface system accordingto another sample embodiment;

FIGS. 66 and 67 schematically illustrate an interface system accordingto another sample embodiment;

FIGS. 68-70 schematically illustrate leak guards according to varioussample embodiments;

FIGS. 71 and 72 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIG. 73 schematically illustrates a patient interface structureaccording to another sample embodiment;

FIG. 74 schematically illustrates a patient interface structureaccording to another sample embodiment;

FIG. 75 schematically illustrates a patient interface structure supportsystem according to a sample embodiment;

FIG. 76 schematically illustrates a patient interface structure supportsystem according to another sample embodiment;

FIG. 77 schematically illustrates a patient interface system accordingto another sample embodiment;

FIGS. 78-81 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 82-84 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 85-87 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 88-90 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 91 and 92 schematically illustrate a patient interface positioningand stabilizing structure according to a sample embodiment;

FIGS. 93 and 94 schematically illustrate a patient interface positioningand stabilizing structure according to another sample embodiment;

FIG. 95 schematically illustrates a patient interface positioning andstabilizing structure according to another sample embodiment;

FIG. 96 schematically illustrates a patient interface positioning andstabilizing structure according to another sample embodiment;

FIGS. 97 and 98 schematically illustrate a patient interface andstabilizing structure according to another sample embodiment;

FIGS. 99 and 100 schematically illustrate a patient interfacepositioning and stabilizing structure according to another sampleembodiment;

FIGS. 101 and 102 schematically illustrate a patient interfacepositioning and stabilizing structure according to another sampleembodiment;

FIGS. 103 and 104 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 105 and 106 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 107 and 108 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 109 and 110 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 111 and 112 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 113 and 114 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIGS. 115 and 116 schematically illustrate a patient interface systemaccording to another sample embodiment;

FIG. 117 schematically illustrates a patient interface structure andconnector according to a sample embodiment;

FIG. 118 schematically illustrates a patient interface structureconnector according to a sample embodiment;

FIGS. 119-121 schematically illustrate a patient interface structureconnector according to another sample embodiment;

FIG. 122 schematically illustrates a patient interface structureconnector according to another sample embodiment;

FIGS. 123 and 124 schematically illustrate a patient interface structureconnector according to another sample embodiment;

FIG. 125 schematically illustrates a patient interface structure andconnector according to a sample embodiment;

FIG. 126 schematically illustrates a patient interface structure andconnector according to another sample embodiment;

FIG. 127 schematically illustrates a patient interface structure andconnector according to another sample embodiment;

FIGS. 128 and 129 schematically illustrate a patient interface structureconnector according to another sample embodiment;

FIG. 130 schematically illustrates a patient interface structureconnector according to another sample embodiment;

FIG. 131 schematically illustrates a patient interface structureconnector according to another sample embodiment;

FIG. 132 schematically illustrates a patient interface structureconnector according to another sample embodiment;

FIG. 133 schematically illustrates a patient interface structureconnector according to another sample embodiment;

FIG. 134 schematically illustrates a patient interface structureconnector according to another sample embodiment;

FIGS. 135-137 schematically depict a patient interface system accordingto another sample embodiment;

FIGS. 138 and 139 schematically depict a patient interface systemaccording to another sample embodiment;

FIGS. 140 and 141 schematically depict a patient interface systemaccording to another sample embodiment;

FIGS. 142 and 143 schematically depict a patient interface systemaccording to another sample embodiment;

FIGS. 144-146 schematically depict a patient interface system accordingto another sample embodiment; and

FIGS. 147 and 148 schematically depict a patient interface systemaccording to another sample embodiment.

DETAILED DESCRIPTION

The following description is provided in relation to several sampleembodiments which may share common characteristics and features. It isto be understood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of thesample embodiments may constitute additional embodiments.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen. It is also acknowledged that the blowersdescribed herein may be designed to pump fluids other than air.

As used herein, the term “patient interface structure” refers to astructure configured to engage the face of a patient and deliver theflow of breathable gas to the patient's airways.

1.0 Positioning and Stabilizing Using Adhesive

Adhesive may be used to secure the patient interface structure inengagement with the patient's airways. Adhesive that is intended toengage the face of the patient will be referred to as the patientadhesive. The patient adhesive may engage the patient's face andposition and stabilize the patient interface structure on the face ofthe user, but it is not necessary for forming a sealing engagement ofthe patient interface with the user. The patient adhesive may berepositionable to allow the patient to adjust the position of thepatient interface structure. In general, the patient adhesive may bemechanically fixed to the patient interface structure or adhesivelyfixed to the patient interface structure. In the following sections arange of technologies that do not require adhesive will be described asmechanical fixation. However in some forms adhesive may be used.Adhesive fixation includes the use of adhesive to join the patientadhesive to the patient interface structure.

1.1.1 Mechanical Fixation First Embodiment

Referring to FIGS. 1-3 b, a patient interface structure may comprise apatient interface structure, e.g. a cushion, 2000 comprising nasalpillows, puffs, or prongs 2002. The patient interface structure 2000 mayalso comprise tabs, or studs, 2004 at opposite ends of a base portion2014. The patient interface structure 2000 may further include anaperture 2006 configured to allow for connection of a tube, hose, orconduit 2008. The tube 2008 may be, for example, a retractable tube,such as disclosed in U.S. Patent Application Publication 2009/0078259A1, the entire contents of which are incorporated herein by reference.

The studs 2004 are each configured to be connected to a patient adhesivestrip 2010 that includes a hole 2012 at a first end. The studs 2004 areinserted through the holes 2012 of the patient adhesive strip 2010 tosecure the patient adhesive strips 2010 to the patient interfacestructure. The top portion of stud 2004 may be wider than hole 2012 suchthat the stud is secured in position once placed through the hole by aninterference fit. The holes 2012 may be reinforced to prevent damage to,or degradation of, the patient adhesive strips 2010. The patientadhesive strips 2010 may be connected to the studs 2004 such that thepatient adhesive strips 2010 are rotatable with respect to the patientinterface structure 2000 in order to locate the patient adhesive strips2010 in the desired position on the face of the patient 1. As shown inFIGS. 3a and 3b , the patient adhesive strips 2010 are engaged with thesides of the nose of the patient 1. The patient adhesive strips 2010include adhesive on one side that is engaged with the side of thepatient's nose.

The patient adhesive strips 2010 may be generally elliptical,rectangular, or any other desired shape. As shown in FIG. 2, theproximal end of the patient adhesive strip 2010, i.e. the end includingthe hole 2012, may be smaller than the distal end that engages the sideof the patient's nose. A middle section of the patient adhesive strip2010 may be narrowed. It should be appreciated that the patient adhesivestrips 2010 may be provided in different sizes and shapes to accommodatea variety of patient facial features.

It should also be appreciated that the patient adhesive strips 2010 mayinclude tabs or studs that are configured to be inserted into holes orapertures provided in the patient interface structure 2000. It shouldalso be appreciated that the patient adhesive strips 2010 may includeadhesive in selected or localized regions, for example, at the distalend that engages the side of the patient's nose.

This embodiment demonstrates an aspect of the present technology wherethe adhesive is used to locate the patient interface in position howeverremains separate from the sealing of the patient interface to thepatient.

1.1.2 Mechanical Fixation Second Embodiment

Referring to FIG. 4, the patient adhesive strips 2010 (only one shown)may include a plurality of holes or spacings 2012 that are eachconfigured to accept the tab or stud 2004 of the patient interfacestructure 2000. As shown in FIG. 4, the plurality of holes 2012 arejoined by a channel 2016 formed in the patient adhesive strip 2010 thatpermits the stud 2004 to be disengaged from one hole and engaged withanother hole without completely disengaging the patient adhesive strip2010 from the stud 2004. The stud 2004 may be disengaged from one hole2012 and engaged with another hole 2012 to permit adjustment of theposition of the patient adhesive strip 2010 without completelydisengaging the adhesive strip 2010 from the patient interface structure2000. It should be appreciated that the holes 2012 of the patientadhesive strip 2010 may be formed separately, i.e. without a channel, sothat adjustment of the position of the patient adhesive strip 2010requires disengagement of the stud 2004 from one hole, and from thepatient adhesive strip 2010, and re-engagement with a different hole andthe patient adhesive strip 2010. It should also be appreciated that thepatient adhesive strip may include a tab or stud and the patientinterface structure may include a plurality of holes each configured toreceive the tab or stud to permit adjustment of the adhesive strip.

1.1.3 Mechanical Fixation Third Embodiment

Referring to FIGS. 5-7, the patient interface system may comprise apatient interface structure 2000 provided with loops 2018 on oppositesides of the patient interface structure 2000. Patient adhesive strips2020 (only one shown) may be inserted through the loops 2018 and lockedin place on the patient interface structure 2000 by locking tabs 2022.The locking tabs 2022 may be rigid or semi-rigid (for example, silicone,polycarbonate, polypropylene, thermoplastic elastomers (TPE), etc.) andare provided to the adjoining ends of the patient adhesive strips 2020.The adhesive 2024 of the patient adhesive strips 2020 may be covered by,for example, release paper 2026 to allow the patient adhesive strips2020 to be inserted through the loops 2018 so that the patient adhesivestrips 2020 can be pulled through the loops 2018 until the locking tabs2022 engage with the loops 2018.

The locking tabs 2022 may be molded onto the patient adhesive strips2020. It should also be appreciated that the locking tabs 2022 may beadhered to the patient adhesive strips 2020. It should further beappreciated that the locking tabs 2022 may be secured within a portionof the patient adhesive strip 2020 by wrapping the patient adhesivestrip 2020 around the locking tab 2022. The wrapped portion of thepatient adhesive strip 2020 may be secured by adhesive, stitching, orany other securement method. The locking tabs 2022 may be secured to thepatient adhesive strip 2020 by any other securement method.

The loops 2018 may be integrally formed with the patient interfacestructure 2000, or they may be separately provided, e.g. clipped orglued, onto the patient interface structure 2000. As shown in FIGS. 5and 6, the loops 2018 may be provided on the base portion 2014 of thepatient interface structure 2000. The base portion 2014 of the patientinterface structure 2000 may include a decoupling arrangement configuredto decouple drag forces on the hose or tube 2008 from the nasal prongs2002 of the patient interface structure 2000. Such a decouplingarrangement is disclosed in, for example, International ApplicationPCT/AU2008/001557, filed Oct. 22, 2008, the entire contents of which areincorporated by reference.

As shown in FIG. 7, the position of the patient adhesive strips 2020 maybe adjusted, as shown in dashed lines, to permit adjustment of theposition of the patient interface structure.

1.1.4 Mechanical Fixation Fourth Embodiment

Referring to FIGS. 8a and 8b , in another sample embodiment of theinvention, a sealing ring 2028 is provided around the aperture 2006 ofthe patient interface structure 2000. The sealing ring 2028 isconfigured to connect a tube or hose to the patient interface structure2000. The sealing ring 2028 includes loops 2030 which are configured toreceive patient adhesive strips 2020 comprising locking tabs 2022 tosecure the patient adhesive strips 2020 to the sealing ring 2028. Thesealing ring 2028 may be part of a decoupling arrangement as disclosedin, for example, International Application PCT/AU2008/001557, filed Oct.22, 2008, the entire contents of which are incorporated by reference.Sealing ring 2028 may be otherwise attached to base portion 2014 of thepatient interface structure 2000, for example, by gluing, co-molding,insert molding, interference fit, or any other suitable means. Sealingring 2028 may be made from a rigid material.

1.1.5 Mechanical Fixation Fifth Embodiment

Referring to FIG. 9, the patient interface structure 2000 may be securedto the patient 1 by connectors 2082. Such connectors are disclosed, forexample, in International Application PCT/AU2008/001557, filed Oct. 22,2008, the entire contents of which are incorporated by reference. Thepatient interface structure 2000 is held in sealing engagement with thenares of the patient by the connectors 2082 which are secured to theface of the patient by adhesive strips 2084 which adhesively secure theconnectors 2082 to the patient 1.

Although a single adhesive strip 2084 is shown for each correspondingconnector 2082 in FIG. 9, it should be appreciated that multiple stripsmay be secured in a variety of places on the patient interface system,or a single piece may be configured around components of the interfacesystem, such as the delivery tube 2008 or a gusset of the base portion2014 of the patient interface structure 2000.

1.1.6 Mechanical Fixation Sixth Embodiment

Referring to FIG. 10, the patient interface system may comprise apatient interface structure 2000 comprising connectors 2086 that areconfigured to secure strips 2088 to the patient interface structure2000. The strips 2088 may be formed of a rigid, semi-rigid, or non-rigidmaterial, for example, of silicone, textile, polycarbonate,polypropylene, nylon, TPE, and may hook around the connectors 2086 andextend upward towards the nose of the patient. The strips 2088 maycomprise adhesive tabs 2090 that are configured to engage the sides ofthe nose of the patient to secure the strips 2088, and thus the patientinterface structure 2000, in engagement with the face of the patient.

1.2.1 Adhesive Fixation First Embodiment

Referring to FIGS. 11a and 11 b, a patient interface system according toanother embodiment may comprise a patient interface structure in theform of a cushion 504 that is adhesively connected to the nose of thepatient 1. The cushion 504 may be connected to a frame, or support, 500that is connectable to a supply of breathable gas by, for example, aretractable tube 2008. The frame 500 may be connected to the retractabletube 2008 by a sealing ring 502. The sealing ring 502 may connect theretractable tube 2008 to the frame 500 so that the retractable tube 2008and the frame 500 are swivelable with respect to one another. The use ofa retractable tube will impart less tube drag forces on the patientinterface structure and thus enable more effective maintenance of themask seal at the nares and/or mouth.

The adhesive may be a sticky element that can mechanically or chemicallyjoin or bond two adjacent members, e.g. the cushion 504 and the nose ofthe patient 1. The adhesive is configured to maintain the patientinterface system, including the cushion 504, in place while minimizingobtrusiveness. The patient interface system allows the patient to sleepin any position and does not obscure any part of the patient's face,thereby enabling the patient to wear, for example, eye glasses or an eyeshield. The attachment of the adhesive to the patient's face is simpleand intuitive and provides a user friendly interface. Compared to otherpatient interface structures and systems currently available, forexample ResMed's SWIFT II™, the adhesively secured patient interfacesystem of FIGS. 11a and 11b is smaller. With the smaller appearance, thepatient interface system will also appear less medical; reducing thepatient's psychological barriers to respiratory treatment, and thereforemay be more appealing to patients. The smaller appearance may alsomotivate and encourage more people to seek treatment for sleep apnea.

In a sample embodiment, the adhesive may be used to locate the patientinterface system on the face of the patient 1. In one form, the adhesivemay not impart any force on the sealing mechanism of the interfacesystem. That is, the sealing of the interface, including the cushion504, is independent or isolated from its attachment to the patient'sface. This means that the interface system will be more comfortable forthe patient to wear as less force will be imposed on the face of thepatient by the adhesive. In other sample embodiments, the adhesive maynot be the only structure that can locate or locate and seal theinterface to the patient's face. For example, a headgear may be used inconjunction with an adhesive to locate the interface.

In one sample embodiment, the cushion 504 may seal on the nares and/ormouth of the patient by, for example, a dual wall silicone, foam, or gelcushion. In another sample embodiment, the cushion may not seal on thenares and/or mouth of the patient and may comprise, for example, nasalcannula(e).

1.2.2 Adhesive Fixation Second Embodiment

Referring to FIG. 12, in another sample embodiment of the invention, thepatient interface system includes a cushion 504 connected to a frame, orsupport, 500. The frame 500 is connected a source of breathable gas by,for example, a retractable tube 2008 that is connected to the frame 500by a sealing ring 502. As shown in FIG. 12, the cushion 504 and theframe 500 are curved to encompass the area around the patient's nares.The curved frame 500 may provide a better sealing engagement forpatient's with higher and/or smaller nares. The cushion 504 may beadhesively connected to the nose of the patient 1.

1.2.3 Adhesive Fixation Third Embodiment

Referring to FIGS. 13a-13f , a patient interface system may comprise apatient interface structure, for example a cushion 504, that isconfigured to be held in sealing engagement with the nose of the patient1 by a strap 506 that comprises adhesive. The strap 506 is configured tobe adhesively connected to the sides of the patient's nose to hold thecushion 504 in the proximity of the nares. The cushion 504 may beconnected to a source of breathable gas by, for example, a retractabletube 2008 as discussed above. The cushion 504 may also be supported by astrap 506 and the cushion 504 may be connected to the tube by, forexample, a sealing ring 502 that may swivelably couple the tube to thecushion 504.

The cushion 504 may comprise an aperture 522 configured to receive thesealing ring 502. The cushion further defines a nasal breathing cavity520 into which the flow of breathable gas is delivered by the tube 6.

As shown in FIGS. 13c-13f , the strap 506 is provided between thecushion 504 and the sealing ring 502. The strap 506 may include adhesive508 that is provided on the same side of the strap as the cushion 504.The strap 506 may be substantially flexible to permit the strap 506 tobe folded around the sides of the patient's nose.

1.2.4 Adhesive Fixation Fourth Embodiment

Referring to FIG. 14, a patient interface structure comprising a cushion504 may have a generally rectangular configuration. The cushion 504defines a nasal breathing cavity 520 having a shape generallycorresponding to the shape of the cushion 504. An adhesive 508 may beprovided on a side of the cushion 504 that is configured for connectionto the sealing ring 502. The adhesive 508 may be used to connect thecushion 504 to a strap in a manner similar to that described above.

1.2.5 Adhesive Fixation Fifth Embodiment

Referring to FIG. 15, an adhesive strip 2032 may be configured tomaintain a patient interface system comprising a patient interfacestructure, e.g. a cushion, 2000 in sealing engagement with the nares ofthe patient 1. The adhesive strip 2032 comprises a bottom portion 2031configured to adhesively engage the patient interface structure 2000 anda top portion 2033 configured to adhesively engage the bridge of thenose of the patient 1. The adhesive strip 2032 may comprisereinforcements 2034 to provide structure and/or force retention tobetter support the patient interface structure 2000. The reinforcementsmay comprise, for example, plastic or metal strips. The adhesiveprovided to the adhesive strip 2032 need not be continuously providedalong the entire length of the adhesive strip 2032. For example, theadhesive may be provided at the bottom portion 2031 and the top portion2033, but not at a portion therebetween, as shown in FIG. 15.

1.2.6 Adhesive Fixation Sixth Embodiment

As shown in FIG. 16, a patient interface system comprising a patientinterface structure 2000 may be provided with connectors 2036 that areconfigured to engage the face, e.g. the nose, of the patient. Adhesivetabs 2038 may be provided at ends of the connectors 2036 to adhesivelysecure the patient interface structure 2000 in sealing engagement withthe nares of the patient. The nasal prongs, or nozzles, 2002 of thepatient interface structure 2000 may be provided with foam cylinders2040 that are configured to sealingly engage the nares of the patient.The cylinders 2040 may be formed of a foam, for example, similar to thatused for earplugs.

1.2.7 Adhesive Fixation Seventh Embodiment

Referring to FIG. 17, a patient interface system comprising a patientinterface structure, e.g. a cushion, 2001 may comprise adhesive 2044that is covered by, for example, release paper 2046. The cushion 2001may be adhesively secured to a mask frame or shell 2042 that includes aflat interface 2048. The adhesive 2044 may be double-sided adhesive thatadheres the cushion 2001 to the mask frame or shell 2042 upon removal ofthe release paper 2046 and engagement of the cushion 2001 and the maskframe or shell 2042 along the interface 2048. The cushion 2001 may beheld in sealing engagement with the face of the patient by, for example,a headgear assembly (not shown) connected to the mask frame 2042.

1.2.8 Adhesive Fixation Eighth Embodiment

As shown in FIG. 18, according to another sample embodiment of theinvention, a patient interface structure comprising a soft mask 2050 maybe attached to the face of the patient 1 by adhesive 2052 that isapplied to the face of the patient. In this instance, the adhesive 2052is configured to act as a seal, or assist in forming a seal between thesoft mask 2050 and the face of the patient 1. As shown, the soft mask2050 is in the form of a full face mask, i.e. a mask that is configuredto cover the patient's mouth and nasal passageways, but it should beappreciated that the soft mask 2050 may be configured to cover only thepatient's mouth or only the patient's nasal passageways.

1.2.9 Adhesive Fixation Ninth Embodiment

Referring to FIG. 19, the patient interface system comprises a patientinterface structure, e.g. a cushion, 2000. The flow of breathable gasmay be delivered to the patient interface structure 2000 by a cannula 2comprising cannula branches 2 a, 2 b that extend on opposite sides ofthe patient's nose. As shown in FIG. 19, the cannula 2, and branches 2a, 2 b may deliver the flow of breathable gas from a position above thepatient's nose. The cannula 2 may be secured to the patient's face, e.g.forehead, by adhesive tape 510.

The cannula branches 2 a, 2 b may be connected to the patient interfacestructure 2000 for delivery of the flow of breathable gas to a nasalbreathing cavity defined by the patient interface structure 2000. Forexample, the patient interface structure 2000 may include apertures thatreceive the cannula branches 2 a, 2 b. As another example, the cannulabranches 2 a, 2 b may be connected to the patient interface structure2000 such that the cannula branches 2 a, 2 b extend through the patientinterface structure 2000 for insertion into the nares of the patient'snose.

In a variant, the patient interface structure 2000 may include nasalprongs or pillows and the interface system may include a headgear, e.g.a strap, and/or the adhesive tape 510.

1.2.10 Adhesive Fixation Tenth Embodiment

Referring to FIGS. 20a and 20b , the patient interface structure 2000may be held in position with the patient's nose by a strap 512, forexample an elastic strap, that is configured to extend around thepatient's head. The strap 512 may extend below the patient's ears,although it should be appreciated that the strap may extend above thepatient's ears, or the strap may be bifurcated to include a portion thatextends below the patient's ears and a portion that extends above thepatient's ears.

A second strap 514 may be connected at opposite ends to the strap 512and extend across the bridge of the patient's nose. The strap 514 maycomprise an adhesive to assist in securing the patient interfacestructure 2000 in position with the patient's nose, for example whentube drag forces act on the patient interface structure 2000.

The flow of breathable gas may be delivered to the patient interfacestructure 2000 by a cannula 2 that comprises two cannula branches 2 a, 2b that extend along each side of the patient's face. The cannulabranches 2 a, 2 b may be secured to the strap 512 to further reduce theeffects of tube drag forces.

1.2.11 Adhesive Fixation Eleventh Embodiment

Referring to FIG. 21, a patient interface structure 2000 is held inposition with a patient's nose by a strap 512, e.g. an elastic strap,configured to extend around the patient's head. A second strap 514,which may comprise adhesive, is connected at opposite ends to the strap512 and extends across the bridge of the patient's nose. A cannula ortube 2 may be connected to the patient interface structure 2000 todeliver a flow of breathable gas to the patient interface structure2000.

1.2.12 Adhesive Fixation Twelfth Embodiment

Referring to FIGS. 22 and 23, the patient interface structure maycomprise a patient interface structure 2000 that may be held inengagement with the face of the patient 1 by adhesive strips 2060. Theadhesive strips 2060 are provided on opposite sides of the patientinterface structure 2000 and are configured to engage the sides of thenose of the patient 1. As shown in FIGS. 22 and 23, a pair of adhesivestrips 2060 is provided to secure the patient interface structure 2000to the patient 1. Each adhesive strip 2060 may be individually adheredto the patient interface structure 2000 to provide for individualadjustment of the attachment of the adhesive strip 2060 to the face ofthe patient 1.

1.2.13 Adhesive Fixation Thirteenth Embodiment

Referring to FIGS. 24 and 25, in another sample embodiment of theinvention, an adhesive strip 2062 comprises an aperture 2064 that isconfigured to extend coextensively with the aperture 2006 of the patientinterface structure 2000. The hose or tube 2008 is securable to thepatient interface structure 2000 through the aperture 2064 of theadhesive strip 2062. The aperture 2064 of the adhesive strip 2062 isconfigured to loop around either the delivery tube 2008 and/or a sealingring connecting the tube 2008 to the patient interface structure 2000.

In a variant shown in FIG. 26, the adhesive strip 2066 comprises asemi-circular loop 2068 that is configured to loop around the tube 2008and/or a sealing ring. As shown in FIG. 26, the loop 2068 extends aroundthe top of the tube 2008, but it should be appreciated that the loop2068 may extend below the tube 2008.

1.2.14 Adhesive Fixation Fourteenth Embodiment

Referring to FIGS. 27 and 28, an adhesive strip 2070 comprises lateralstrips 2072 that are configured to engage the sides of the patient'sface, for example the cheeks. A nasal bridge strip portion 2074 isconfigured to extend along the bridge of the patient's nose and extendsto a nasal bridge lateral strip 2076 that is configured to extendlaterally across the bridge of the patient's nose. As shown in FIG. 27,the adhesive strip 2070 includes a loop 2071 extending around the top ofthe delivery tube 2008, but it should be appreciated that the adhesivestrip 2070 may include an aperture, similar to the one shown in FIG. 24and extend completely around the delivery tube 2008.

1.2.15 Adhesive Fixation Fifteenth Embodiment

Referring to FIG. 29, the patient interface structure 2000 may comprisea pair of nasal pillows 505 (only one shown). Each nasal pillow 505 maycomprise a generally cylindrical portion 507 and a conical portion 509configured to sealingly engage a nare of the patient. The patientinterface structure 2000 may include a flexible base portion 519defining a nasal breathing cavity 520. Such a flexible base portion isdisclosed in, for example, International Application PCT/AU2008/001557,filed Oct. 22, 2008, the entire contents of which are incorporatedherein by reference. The pair of nasal pillows 505 may be connected to aflow of breathable gas delivered by a tube that is connected to thepatient interface structure 2000 by a sealing ring 502. Adhesive 529 maybe provided to the bottom of the base portion 519 to allow the cushion504 to connect to a strap in a manner similar to that described above.

The nasal pillows may be as disclosed, for example, U.S. PatentApplication Publications 2007/0144525 A1 and 2006/0283461 A1, andInternational Application PCT/AU2008/001557, filed Oct. 22, 2008, theentire contents of each being incorporated herein by reference. Itshould also be appreciated that the nasal pillows may be as describedin, for example, U.S. Pat. No. 7,318,437, the entire contents of whichare incorporated herein by reference. It should further be appreciatedthat in addition to nasal pillows, the patient interface structure mayinclude nasal pillows or prongs as disclosed, for example, in U.S. Pat.No. 4,782,832 (Trimble), U.S. Pat. No. 7,201,169 (Wilkie et al.), U.S.Pat. No. 7,059,328 (Wood), and WO 2000/074758 (Lovell). It should alsobe appreciated that the cannula(e) and/or nasal pillows or prongs mayinclude features configured to diffuse the flow of air so that noise maybe reduced. Such features are disclosed in, for example U.S. PatentApplication Publication 2009/0044808 A1, and WO 2008/014543 A1, theentire contents of each being incorporated herein by reference.

1.2.16 Adhesive Fixation Sixteenth Embodiment

Referring to FIG. 30, the patient interface structure 2000 may besupported by a frame 2078 that is, for example, formed of a clear, ortransparent, flexible material. The frame 2078 comprises an aperture2079 that is configured to be coextensive with the aperture 2006 of thepatient interface structure 2000. The frame 2078 also comprises adhesive2080, for example an adhesive strip, that is configured to adhesivelysecure the frame 2078 to the face of the patient.

1.2.17 Adhesive Fixation Seventeenth Embodiment

Referring to FIGS. 31-33, the patient interface structure 2000 may beconnected to a sealing ring 2092 that is configured to connect adelivery tube or conduit to the patient interface structure 2000. Thesealing ring 2092 may comprise a shroud 2094 that is configured toextend along the flexible base portion 2014 of the patient interfacestructure 2000. As shown in FIG. 33, adhesive strips 2096 (only oneshown) may be secured to the shroud 2094 and to the patient's face, forexample, along the sides of the patient's nose, to secure the patientinterface structure 2000 in sealing engagement with the patient'sairways.

1.2.18 Adhesive Fixation Eighteenth Embodiment

Referring to FIG. 34, the patient interface structure 2000 may beconnected to a stiffening element, or rigidizer, 2098 that is secured tothe face of the patient by adhesive 2100. The stiffening element orrigidizer 2098 may be formed, for example, of non-silicone, and theadhesive may be chosen for securing a non-silicone component. It shouldalso be appreciated that the adhesive may be used to join othernon-silicone components to the patient's face, for example, a sealingring or headgear.

1.2.19 Adhesive Fixation Nineteenth Embodiment

As shown in FIG. 35, the patient interface structure 2000 may compriseconnectors 2102 extending from opposite sides. The connectors 2102 maycomprise a hinge 2106 which may be formed by a portion of the connectors2102 that has been reduced in thickness. The ends of the connectors 2102may comprise adhesive 2104 which may be a tacky gel that is co-molded orotherwise integrated with the connectors 2102. The tackiness of the geladhesive 2104 will cause the gel to adhere to the face of the patientthus securing the nasal prongs or pillows 2002 of the patient interfacestructure 2000 in sealing engagement with the patient.

1.2.20 Adhesive Fixation Twentieth Embodiment

Referring to FIG. 36, the nasal prongs or pillows 2002 of the patientinterface structure 2000 may be provided with adhesive 2108 that may be,for example, a tacky gel co-molded with the patient interface structure2000. The adhesive 2108 is thereby provided at the sealing interface ofthe patient interface structure 2000. As shown in FIG. 37, in additionto the adhesive 2108 provided on the nasal prongs or pillows 2002,additional adhesive 2110, in the form of tacky gel for example, may beprovided on the flexible base portion 2014 of the patient interfacestructure 2000 in a location that does not form a sealing engagementwith the face of the patient. The adhesive 2110 may thus adhere to, forexample, the upper lip and/or cheeks of the patient.

Referring to FIGS. 38 and 39, adhesive 2112, which may be a co-moldedtacky gel, on the base portion 2014 of the patient interface structure2000 is configured to adhesively secure the patient interface structure2000 to the upper lip 2114 of the patient.

1.2.21 Adhesive Fixation Twenty-First Embodiment

Referring to FIGS. 40-42, the patient interface system may compriseadhesive strips 2116 that are adhesively securable to the patientinterface structure 2000. As shown in FIG. 41, the adhesive strips 2116may comprise adhesive divided into two portions. An adhesive 2118 isconfigured for securing the adhesive strips 2116 to the patientinterface structure 2000 which may be formed of, for example, ofsilicone material. The adhesive strips 2116 may also comprise anadhesive 2120 that is configured to adhesively secure to the skin of thepatient. The adhesive 2120 for securing the interface structure 2000 tothe skin of the patient may be, for example, a synthetic rubber (e.g.hydrocolloid).

The adhesive 2120 may releasably adhere the strips 2116 to the face ofthe patient to permit adjustment of the fit of the patient interfacestructure 2000 to the face of the patient, as shown in FIG. 40.

1.2.22 Adhesive Fixation Twenty-Second Embodiment

Referring to FIGS. 43 and 44, in another sample embodiment of theinvention, the patient interface structure 2000 is adhesively secured toan adhesive strip 2122 that includes a loop 2124 comprising an aperture2126 that is configured to be coextensive with the aperture 2006 of thepatient interface structure 2000 when the adhesive strip 2122 is securedto the patient interface structure 2000. The loop 2124 is provided withadhesive 2118 that is configured to adhere to, for example, the siliconematerial of the patient interface structure 2000. The ends of theadhesive strip 2122 may comprise adhesive 2120 that is configured toadhere to the skin of the patient.

Although the patient interface systems shown in FIGS. 40-44 show one ortwo adhesive strips provided to the system, it should be appreciatedthat multiple adhesive strips may be provided, for example three orfour. Each adhesive strip of the system may be provided with twoadhesive regions, i.e. a patient interface structure engaging adhesiveand a patient, or skin engaging, adhesive.

1.2.23 Adhesive Fixation Twenty-Third Embodiment

Referring to FIGS. 45-47, the patient interface structure 2000 maycomprise connector strips 2128 extending from opposite sides. Theconnector strips 2128 may be integrally formed with the patientinterface structure 2000, or separately provided and secured to thepatient interface structure 2000. The ends of the connector strips 2128may comprise double sided adhesive strips 2130, 2132. The double sidedadhesive strip 2132 may comprise adhesive that is configured to secureto the material of the connector strips 2128, which may be formed, forexample, of silicone. The double sided adhesive strips 2130 may compriseadhesives that are configured to secure the connector strips 2128 to theskin of the patient. The adhesive strips 2130 may be, for example,synthetic rubber.

An intermediate portion 2134 may be provided between the double sidedadhesive strips 2130, 2132 to form an impermeable barrier and preventcontamination of each double sided adhesive strip 2130, 2132. It shouldbe appreciated, however, that the double sided adhesive strips 2130,2132 may be bonded together without an intermediate portion therebetweenor that a single double sided adhesive strip may be provided to eachconnector strip 2128.

2.0 Positioning and Stabilizing Using Adhesive and Additional FasteningArrangements

It may be desirable to provide fastening arrangements in addition toadhesive for positioning and stabilizing the patient interface structurein engagement with the patient's face. The use of additional fasteningarrangements, or materials, permit the position of the patient interfacestructure and/or the position of the fastening arrangement to beadjusted to provide a comfortable fit while providing efficient therapyvia the flow of breathable gas.

2.1.1 Adhesive and Hook and Loop Fastening Material First Embodiment

Referring to FIGS. 48 and 49, an adhesive strip 2136 may comprise hookor loop fastener material 2138 on an opposite side to the adhesive layersuch that the hook or loop fastener material 2138 may be on thenon-patient contacting side of the adhesive strip 2136. The adhesivestrip 2136 may be applied to the face of the patient, for example,across the nasal bridge or cheeks, with the hook or loop fastenermaterial 2138 provided to the top of the strip 2136. A frame or support2140 may engage the patient interface structure 2000, which may comprisea flexible base portion and a pair of nasal pillows or prongs. The frameor support 2140 comprises corresponding loop and hook fastener material2142 configured to engage the hook and loop fastener material 2138 ofthe adhesive strip 2136 to secure the patient interface structure 2000in sealing engagement with the patient's airways.

As shown in FIG. 48, the hook or loop fastener material 2138 is providedat opposite portions of the strip 2136. It should be appreciated thatthe hook and loop fastener material may be continuous across theadhesive strip 2136, or may be provided in zones or areas of theadhesive strip 2136.

The frame or support 2140 may be connected to the patient interfacestructure 2000 by any method, for example, gluing, co-molding orinterference fit. It should also be appreciated that the hook and loopfastener material 2138, 2142 may be formed of any material, such asmetal or plastic.

2.1.2 Adhesive and Hook and Loop Fastening Material Second Embodiment

Referring to FIGS. 50a-50c , the patient interface structure 2000 maycomprise connector strips 2144 provided at opposite ends. The connectorstrips 2144 may comprise hook or loop fastener material 2145 that issecurable to the loop or hook fastener material 2138 of the adhesivestrip 2136. The connector strips 2144 may be connected to the patientinterface structure 2000 through, for example, loops 2018, 2147, asdescribed above. For example, the loops 2018 may be integrally formed onopposite sides of the flexible base portion 2014 of the patientinterface structure 2000. As another example, the connector strips 2144may be connected to a sealing ring 2028 or a swivel elbow 2008 connectedto the patient interface structure 2000.

As shown in FIGS. 48-50 c, the adhesive strip 2136 may include a regionin which no fastener material and/or adhesive is provided. For example,the portion of the adhesive strip 2136 between the fastener materials2138 may not be provided with fastener material and/or adhesive. Theadhesive strip 2136 may also include a peripheral region that does notinclude fastener material and/or adhesive, for example as shown in FIG.48 that permits the adhesive strip to be engaged by the patient's orclinician's fingers to facilitate removal of the support 2140 or theconnectors 2144 from the adhesive strip 2136 and/or to facilitateremoval of the adhesive strip 2136 from the patient's face.

2.1.3 Adhesive and Hook and Loop Fastening Material Third Embodiment

Referring to FIGS. 51a and 51b , a patient interface structure 2000includes a flexible base portion 2014 and connectors 2200 provided oneach side of the flexible base portion 2014. The connectors 2200 mayeach comprise hook material 2202 provided thereon. The hook material2202 may be provided on an adhesive strip that is adhered to theconnector 2200. It should be appreciated, however, that the hookmaterial may be attached to the connectors 2200 by other mechanisms.

The hook material 2202 is configured to engage with loop materialprovided on an adhesive nasal strip (not shown, but may be similar to,for example, the adhesive strip 2136 shown in FIGS. 5a-50c ) that isconfigured to be placed across the bridge of the patient's nose. Itshould also be appreciated that the connectors 2200 may have the loopmaterial provided thereon and the adhesive nasal strip may have hookmaterial provided thereon.

A wire 2204 may be connected between the connectors 2200. For example,the ends of the wire 2204 may be connected to the connectors 2200 byadhesive strips on which the hook material 2202 is provided. The wire2204 may be preloaded to force the patient's nostrils to flare outwardswhen the hook material 2202 is connected to the loop material of theadhesive nasal strip that is adhered across the bridge of the patient'snose.

The wire may be formed, for example, of metal and may be connected tothe loop or hook material 2202 by adhesive or co-molding, or any othermechanism.

2.1.4 Adhesive and Hook and Loop Fastening Material Fourth Embodiment

Referring to FIGS. 52a and 52b , the patient interface structure 2000may comprise the flexible base portion 2014 and a pair of stiffeningmembers 2206 that connect to the flexible base portion 2014 and extendalong the connectors 2200 that include the hook material 2202. Thestiffening members 2206 may be configured to provide an outward bias tothe connectors 2200 to force the patient's nostrils to flare outwardswhen the hook material 2202 is connected to the loop material of theadhesive nasal strip across the bridge of the patient's nose. Thestiffening members 2206 may be formed of, for example, metal, TPE,polycarbonate, polypropylene, and may be connected to the connectors2200 by, for example, adhesive or co-molding.

2.1.5 Adhesive and Hook and Loop Fastening Material Fifth Embodiment

Referring to FIG. 53, the patient interface structure 2000 may be heldin engagement with the nares of the patient by connectors 2208 that arefastened to a nose cap 2212 that is held across the patient's nose by ahead strap 2210. The nose cap 2212 may include loop material thatfastens with hook material provided on the connectors 2208, or viceversa.

The head strap 2210 loops around the patient's head and hooks over thepatient's ears to avoid the patient's eyes. The nose cap 2212 may beconfigured to cover all, or part, of the patient's nose. The head strap2210 and/or the nose cap 2212 may be made from a rigid material, or aflexible material (e.g. TPE), or a combination of rigid and flexiblematerial.

It should be appreciated that the connectors 2208 may connect to thenose cap 2212 by other fastening mechanisms, for example, magnetic orelectrostatic.

2.1.6 Adhesive and Hook and Loop Fastening Material Sixth Embodiment

Referring to FIG. 57, a patient interface system may comprise a headstrap 2224 that is configured to extend around the head of the patient.The head strap 2224 may comprise an adjustment mechanism 2230, forexample, a hook or loop fastening material. A stiffening element, orrigidizer, 2226 may be connected to the adjustment mechanism 2230, forexample, by respective loop or hook fastening material. The rigidizer2226 may be rotated or slid along the head strap 2224 to allowadjustment of the position of the rigidizers 2226. Each rigidizer (onlyone shown in FIG. 57) may comprise connectors 2228 configured to connectto a patient interface structure that engages with the nose of thepatient, for example, by being connected to connectors provided to thepatient interface structure. The connectors 2228 may be hook or loopfastening material, magnetic, or electrostatic connecting mechanisms.

2.1.7 Adhesive and Hook and Loop Fastening Material Seventh Embodiment

Referring to FIGS. 59a and 59b , an adhesive strip 2164 comprising hookfastener material may be secured to, for example, the bridge of thepatient's nose. A patient interface 2166, for example a nasal mask whichmay comprise a mask frame and a cushion, may be provided with loopfastener material 2168 on an interior portion thereof for engagementwith the hook fastener material of the adhesive strip 2164. As shown inFIG. 59b , the patient secures the nasal mask 2166 in sealing engagementby securing the loop fastener material 2168 of the nasal mask 2166 withthe hook fastener material of the adhesive strip 2164.

The hook fastener material 2168 is placed on the inner surface of theframe of a nasal mask, for example at the nasal bridge region. The loopfastener material 2168 in the frame of the nasal mask 2166 may need tobe ‘built up’ or thickened so as to contact the patient's nose where theadhesive strip 2164 with corresponding hook fastener material isattached.

It should also be appreciated that the configuration shown is not theonly possible location for attachment of the hook and loop materials.For example, the mask may be a full face mask and the adhesive strip(s)2164 may be provided in, for example, the cheek region, the upper lipregion, and/or a chin region. The hook and loop materials may also be inthe reversed configuration, i.e. hook fastener material inside the maskand loop fastener material on the adhesive strip.

The embodiments shown in FIGS. 48-53, 57 and 59 a-59 b include hook andloop fastener material. However, it should be appreciated that otherforms of attachment may be used, for example magnets. The magnets may beprovided to the adhesive strip and/or the frame or support and/or theconnector strips 2144. The magnets may be connected by any method, forexample gluing, welding, co-molding, or an interference fit.

The adhesive strip 2164 may be configured to extend across the bridge ofthe patient's nose but avoid the soft skin under the eyes. The adhesivestrip 2164 may also be configured to not extend along the creases wherethe nose meets the sides of the patient's cheeks. The adhesive strip2164 may also be configured not to cover areas of the patient's facethat move. The adhesive strip 2164 may have an area that is large enoughto assemble the patient interface structure to the adhesive strip andmaintain the connection between the hook and loop fastener materials.

2.1.8 Adhesive and Hook and Loop Fastening Material Eighth Embodiment

Referring to FIGS. 78-81, a patient interface system includes a patientinterface structure 6000 having connectors 6002 on opposite sides. Theconnectors 6002 may be integrally formed with the patient interfacestructure 6000, although it should be appreciated that they may beseparately provided and attached to the patient interface structure6000. A flow of breathable gas is delivered through a tube, or conduit,2008 that is connected to the patient interface structure 6000 by anelbow 6006. The patient interface structure 6000 is secured to thepatient in sealing engagement with the patient's airways by an adhesivestrip 6004 that is configured to be connected with the connectors 6002.The connector 6002 may have hook fastening material 6008 that engageloop fastening material on the adhesive strip 6004. As shown in FIGS. 80and 81, the hook fasteners 6008 may be secured to the connector 6002 by,for example, ultrasonic welding the hook fastener 6008 to the connector6002. A backing pad 6010 may be provided on the opposite side of theconnector 6002 to allow the hook fastener 6008 to be ultrasonicallywelded to the connectors 6002, i.e. to prevent damaging the hookfasteners.

2.1.9 Adhesive and Hook and Loop Fastening Material Ninth Embodiment

Referring to FIGS. 82-84, in another sample embodiment, the patientinterface structure 6000 may be held in sealing engagement with thepatient's airways by connectors 6014 that are connected to the elbow6012. The ends 6020 of the connectors 6014 may include hook fastenersthat engage loop fasteners provided on an adhesive strip 6004 that isadhered across the bridge of the patient's nose. As shown in FIG. 84,the hook fastener 6016 may be connected to the ends 6020 of theconnector 6014 by, for example, ultrasonic welding. The connector 6014may include living hinges 6018 that allow the ends 6020 of the connector6014 to extend around the patient interface structure 6000 and engagethe adhesive strip 6004.

2.1.10 Adhesive and Hook and Loop Fastening Material Tenth Embodiment

As shown in FIGS. 85-87, a patient interface system according to anothersample embodiment includes a patient interface structure 6000 configuredto sealingly engage the airways of the patient, e.g. the nares. Thepatient interface structure 6000 may include nasal puffs or pillows orprongs that are configured to engage the nares of the patient.Connectors 6022 are connected to the patient interface structure 6000 byretention portions 6024 that secure the ends of the connector 6022 tothe patient interface structure 6000. The patient interface structure6000 may include slots through which the connector 6022 may be inserteduntil the retention portions 6024 engage the patient interface structure6000. As shown in FIG. 87, the connectors 6022 include hook fasteners6026 that are connected to the connectors by, for example, ultrasonicwelding. The connectors 6022 may be formed of, for example, fabric. Theretention portions 6024 of the connectors 6022 may be formed by heat.

2.1.11 Adhesive and Hook and Loop Fastening Material Eleventh Embodiment

Referring to FIGS. 135-137, the patient interface structure 6000 may beconnected to a tube 2008 for delivering a flow of breathable gas by anelbow 6006. The patient interface structure 6000 may also compriseconnectors 6230 that include hook fasteners 6234 that engage loopfasteners provided on an adhesive strip 6004 that is adhered to thepatient's nose. The connectors 6230 may include a thickened portion 6232that reduce the torsional force translated to the end of the connector6230 that includes the hook fasteners 6234.

2.1.12 Adhesive and Hook and Loop Fastening Material Twelfth Embodiment

Referring to FIGS. 138 and 139, the connectors 6236 may be thickenedthroughout the entire length of the connector 6236. The connectors 6236may be stiffer than other sample embodiments disclosed herein but mayprovide a more secure feeling to the patient.

2.1.13 Adhesive and Hook and Loop Fastening Material ThirteenthEmbodiment

Referring to FIGS. 140 and 141, the connectors 6238 of the patientinterface structure 6000 may include ridges 6240 on edges of theconnectors 6238 that provide stiffening of the connectors 6238. Theridges 6240 allow the connectors 6238 to twist about a longitudinal axisof the connector 6238 to adapt the fit to the nose of the patient, butprovide a stiffer feeling in a direction perpendicular to thelongitudinal direction of the connector 6238 along the sides of thepatient's nose.

2.1.14 Adhesive and Hook and Loop Fastening Material FourteenthEmbodiment

As shown in FIGS. 142 and 143, according to another sample embodiment,the connector 6242 of the patient interface structure 6000 include athickened portion 6244 that narrows at a position corresponding to thehook fasteners 6234. This arrangement may provide a secure feeling tothe patient, while retaining comfort.

2.1.15 Adhesive and Hook and Loop Fastening Material FifteenthEmbodiment

Referring to FIGS. 144-146, the connectors 6248 of the patient interfacestructure 6000 include legs 6250. The length of the legs 6250 may beadjusted for individual patients to provide the most secure andcomfortable fit.

2.1.16 Adhesive and Hook and Loop Fastening Material SixteenthEmbodiment

As shown in FIGS. 147 and 148, the adhesive strip 6004 including theloop fasteners may be provided to extend from the bridge of thepatient's nose to the upper lip region. The patient interface structure6000 may include connectors 6252, 6254 that include hook fasteners 6234that engage the loop fasteners of the adhesive strip 6004. Theconnection of the hook fasteners 6234 to the loop fasteners of theadhesive strip 6004 provide forces that seal and stabilize the patientinterface structure 6000 in engagement with the patient's nose.

2.2.1 Positioning and Stabilizing Using Adhesive and Providing NasalDilation First Embodiment

Referring to FIGS. 65a and 65b , the patient interface structure 2000may comprise a spring 2174 that is configured to engage the nares of thepatient's nose. The spring 2174 may be attached at opposite ends toadhesive strips 2172. The spring 2174 is configured to bias the bottomof the nasal prongs or pillows 2002 to a dilated position. The adhesivestrips 2174 are configured to be attached to the sides of the patient'snose to secure the patient interface structure 2000 in sealingengagement with the patient's nares.

2.2.2 Positioning and Stabilizing Using Adhesive an Providing NasalDilation Second Embodiment

Referring to FIG. 66, the patient interface system may comprise alateral nasal bridge adhesive strip 2176 configured to extend across thebridge of the patient's nose. The lateral strip 2176 may also beconfigured to dilate the nasal passages, e.g., as done by Breathe RightStrips™. The lateral strip 2176 may be integrated with a longitudinalnasal bridge adhesive strip 2178 which is incorporated with a loopedadhesive strip 2180 that is configured to adhesively engage the cushionand lateral adhesive strips 2182 that are configured to adhesivelyengage the sides of the patient's face, e.g. the cheeks.

2.3 Positioning and Stabilizing Nasal Cradle and Adhesive

Referring to FIGS. 60a and 60b , a semi-rigid or rigid cradle 2148 mayextend along the bridge of the patient's nose and form a cup under, orat, the nares of the patient. A cradle 2148 is configured to positionthe interface system at the nares of the patient. An adhesive strip 2146may be provided to secure the cradle 2148 on the bridge of the patient'snose. The adhesive strip 2146 may extend, for example, to the cheeks ofthe patient for additional adhesion strength.

2.4 Positioning and Stabilizing Adhesive Strips with Multiple ContactPoints

Referring to FIGS. 61 and 62, an adhesive strip 2150 may be secured tothe patient interface system and connect to the face of the patient attwo points. As shown in FIG. 61, the adhesive strip 2150 may connect tothe sides of the patient's nares and/or nasal bridge. As shown in FIG.62, the adhesive strip 2150 may connect to the face of the patient atthe cheeks.

As shown in FIGS. 63a and 63b , the adhesive strip 2152 may secure thepatient interface system, for example the patient interface structure2000, to the patient's face at three points. The adhesive strip 2152 mayinclude a nasal bridge strip 2154 configured to extend along thepatient's nasal bridge and may comprise lateral strips 2156 configuredto extend across the bridge of the patient's nose as shown in FIG. 63a ,or along the cheeks of the patient as shown in FIG. 63 b.

An adhesive strip 2158 may be provided to connect to the patient's faceat four points, as shown in FIG. 64. The adhesive strip 2158 maycomprise nasal bridge strips 2160 configured to engage the sides of thepatient's nose and lateral strips 2162 configured to engage the cheeksof the patient.

It should also be appreciated that the connection between the strip(s)on the patient interface structure and the strip(s) on the patient maybe formed by other methods, including, for example, friction orelectrostatic connection.

3.0 Positioning and Stabilizing Using Additional Arrangements 3.1.1Positioning and Stabilizing Additional Arrangement First Embodiment

Referring to FIG. 54, a patient interface structure 2000 is connected toa tube 2008 for delivery of a flow of breathable gas. The patientinterface structure 2000 is connected to a rigid glasses type frame 2214by connectors 2216 on opposite sides of the patient's nose (only oneconnector shown in FIG. 54). The rigid glasses type frame 2214 acts as ahead strap in maintaining the patient interface structure 2000 inengagement with the nose of the patient.

3.1.2 Positioning and Stabilizing Additional Arrangement SecondEmbodiment

As shown in FIG. 55, a patient interface structure 2000 is held inengagement with the nose of the patient by a rigid, or semi-rigid, firsthead strap portion 2218 that is connected to a flexible second headstrap 2220 that allows for adjustment of the first head strap 2218.

3.1.3 Positioning and Stabilizing Additional Arrangement ThirdEmbodiment

As shown in FIG. 56, the patient interface structure 2000 may be held inengagement with a nose of the patient by a flexible head strap 2222 thatpasses over the ears of the patient.

3.1.4 Positioning and Stabilizing Additional Arrangement FourthEmbodiment

Referring to FIG. 58, the patient interface system may include a headstrap 2224 that is connected to a vertical connector 2232 that isconnected to the patient interface structure 2000 to maintain thepatient interface structure 2000 in engagement with the nose of thepatient. The vertical connector 2232 may be connected between the headstrap 2224 and the patient interface structure 2000 to provide a force Fthat produces a moment M that acts to maintain the patient interfacestructure 2000 in engagement with the nose of the patient.

3.2 Positioning and Stabilizing—Headgear 3.2.1 Positioning andStabilizing—Headgear First Embodiment

Referring to FIGS. 88-90, a patient interface system comprises a patientinterface structure 6000 having connectors 6032 on opposite sides. Theconnectors 6032 may comprise hook fasteners that are, for example,molded in place. The connectors 6032 are connected to a strap 6028 thatis configured to extend around the face of the patient past thepatient's cheeks and extending over and around the forehead of thepatient. The straps 6028 may comprise loop fasteners that engage thehook fasteners on the connectors 6032. A back strap 6030 may be providedto extend around the back of the patient's head to assist in maintainingthe straps 6028 in engagement with the patient's face.

3.2.2 Positioning and Stabilizing—Headgear Second Embodiment

As shown in FIGS. 91 and 92, a patient interface system according toanother sample embodiment includes a patient interface positioning andstabilizing structure 6036 that is configured to engage the face of thepatient. The positioning and stabilizing structure 6036 may take theform of a band that extends around the forehead of the patient, the eyesof the patient and over the bridge of the patient's nose. Thepositioning and stabilizing structure 6036 may be formed of, forexample, TPE. The positioning and stabilizing structure 6036 may includea backwardly extending portion 6046 that engages the top of thepatient's head and provides spring forces 6042 to the positioning andstabilizing structure 6036 to assist in retaining the positioning andstabilizing structure 6036 in engagement with the face of the patient.

The positioning and stabilizing structure 6036 may also include aconnector 6038 that is configured to be connected to a verticalconnector, such as for example the one shown in FIG. 58, to maintain apatient interface structure in sealing engagement with the nose of thepatient. The connectors 6038 may comprise, for example, adhesive or ahook or loop fastener material that is configured to connect to thevertical connector.

As shown in FIG. 92, the positioning and stabilizing structure 6036 maycomprise an adhesive tab 6044 to assist in maintaining the positioningand stabilizing structure 6036 in engagement with the face of thepatient.

3.2.3 Positioning and Stabilizing—Headgear Third Embodiment

Referring to FIGS. 93 and 94, a patient interface positioning andstabilizing structure 6048 includes a strap 6050 extending generallyacross the forehead of the patient and side straps 6052 generallyextending along the cheeks of the patient and connected to a nasalbridge strap 6054 extending across the bridge of the patient's nose.Side straps 6058 extend along the sides of the patient's head andconnect to a back strap 6056 that is configured to engage the back ofthe patient's head, for example, by circling the back of the patient'shead. The nasal bridge strap 6054 may include loop fasteners that engagehook fasteners provided on connectors that are connected to the patientinterface structure to maintain the patient interface structure insealing engagement with the nose of the patient.

3.2.4 Positioning and Stabilizing—Headgear Fourth Embodiment

A patient interface positioning and stabilizing structure 6060 accordingto another sample embodiment is shown in FIG. 95 and comprises a crownstrap 6066 that is configured to engage the crown of the patient's head.Side straps 6068 extend from the crown strap 6066 and are connected to achin strap 6062. A nasal bridge strap 6064 is connected between the sidestrap 6068 and is configured to engage the bridge of the patient's nose.The nasal bridge strap 6064 may include, for example, loop fastenermaterial configured to connect to hook fastener material provided onconnectors of a patient interface structure. It should be appreciatedthat the nasal bridge strap 6064 may be formed as a rigid member.

3.2.5 Positioning and Stabilizing—Headgear Fifth Embodiment

Referring to FIG. 96, a patient interface positioning and stabilizingstructure 6070 may include a crown strap 6074 and side straps 6072.Lower straps 6076 may extend around the patient's head under thepatient's ears and be connected to a strip 6072 of loop fastenermaterial that may include adhesive to adhere the strip 6072 to the noseof the patient 1.

3.2.6 Positioning and Stabilizing—Headgear Sixth Embodiment

As shown in FIGS. 97 and 98, a patient interface positioning andstabilizing structure 6078 according to another sample embodimentincludes vertical straps 6082 that extend from a connector 6080 that isconnected to back straps 6088. Side straps 6086 are connected to a stripof loop fastener material 6084 which is also connected to the verticalstrap 6082. The side straps 6086 and the back straps 6088 are connectedby connectors 6081 at the back of the patient's head.

3.2.7 Positioning and Stabilizing—Headgear Seventh Embodiment

Referring to FIGS. 99 and 100, a patient interface positioning andstabilizing structure 6090 according to another sample embodimentincludes a vertical strap 6092 that extends from a crown strap 6094. Thevertical strap 6090 is connected to a strip of loop fastener material6096 that is configured to engage hook fastener material provided onconnectors of a patient interface structure that sealingly engages thenose of the patient. The strip 6096 may comprise adhesive to adhere thestrip to the patient's nose. Side straps 6098 are also connected to thestrip 6096 and extend around the sides of the patient's face beneath thepatient's ears as shown in FIG. 100. Back straps 6102 are connected tothe side straps 6098 and to the crown strap 6094 at a connector 6100. Asshown in FIG. 100, the position of the back straps 6102 may be adjusted,as shown by the arrow, to accommodate patients having different headsizes, or to adjust the fit of a particular patient according to thecomfort of the patient.

3.2.8 Positioning and Stabilizing—Headgear Eighth Embodiment

As shown in FIGS. 101 and 102, a patient interface positioning andstabilizing structure 6104 according to another embodiment comprises anasal bridge strap 6108 that extends across the bridge of the patient'snose. The nasal bridge strap 6108 is connected to a chin strap 6106 thatengages the chin of the patient. A back strap 6110 is connected to thenasal bridge strap 6108 and the chin strap 6106 and extends around theback of the patient's head to secure the patient interface positioningand stabilizing structure 6104 on the face of the patient.

3.2.9 Positioning and Stabilizing—Headgear Ninth Embodiment

As shown in FIGS. 103 and 104, a patient interface positioning andstabilizing structure comprises rigid member 6112 that extends acrossthe face of the patient and engages the ears of the patient. The patientinterface structure 6000 includes connectors 6114 that engage the rigidmember 6112 to position and stabilize the patient interface structure6000 in sealing engagement with the nose of the patient. The connectors6114 may adjustably engage the rigid member 6112 to allow the fit of thepatient interface structure 6000 with the nose of the patient to beadjusted.

3.2.10 Positioning and Stabilizing—Headgear Tenth Embodiment

Referring to FIGS. 105 and 106, the patient interface structure 6000includes connectors 6002 that include, for example, hook fasteners. Theconnectors 6002 engage an adhesive strip 6004 that extends across thebridge of the patient's nose and includes loop fasteners that engage thehook fasteners of the connector 6002. A strap 6116 may be connected tothe patient interface structure 6000 by connector 6118 and extend aroundthe back of the patient's head to assist in maintaining the patientinterface structure 6000 in engagement with the nose of the patient. Thestrap 6116 may be, for example, a high stretch tape.

3.2.11 Positioning and Stabilizing—Headgear Eleventh Embodiment

As shown in FIGS. 107 and 108, the sealing engagement of the patientinterface structure 6000 with the nose of the patient may be assisted bya strap 6120 that is connected to the patient interface structure 6000and extends around the patient's head, for example, under the ears ofthe patient. The straps 6120 may be an elastic strap.

3.2.12 Positioning and Stabilizing—Headgear Twelfth Embodiment

Another sample embodiment is shown in FIG. 109 which depicts the patientinterface structure 6000 connected to straps 6124 by connectors 6118.The straps 6124 may be connected to a strap 6122 that extends around theback of the patient's head. The straps 6124 may be formed of, forexample, elastic, TPE, or silicone. The strap 6122 may be, for example,a soft textile strap.

3.2.13 Positioning and Stabilizing—Headgear Thirteenth Embodiment

As shown in FIG. 110, the sealing engagement of the patient interfacestructure 6000 with the nose of the patient may be assisted by straps6126 that are connected to the patient interface structure 6000 byconnectors 6118. The straps 6126 may include ear loops 6128 that areconfigured to loop around the ears of the patient to maintain the straps6126 in engagement with the face of the patient to permit the straps6126 to assist in maintaining the patient interface structure 6000 insealing engagement with the patient's nose.

3.3 Positioning and Stabilizing—Headgear Tabs 3.3.1 Positioning andStabilizing—Headgear Tabs First Embodiment

Referring to FIG. 117, a connector 6138 configured to connect thepatient interface structure 6000 to a strip 6138 that may be adhered tothe nose of the patient and that includes hook fasteners 6140. The hookfasteners 6140 are configured to engage loop fasteners on a stripadhered to the nose of the patient. The connector 6138 includes anaperture 6142 that is configured to receive a tab 6144 of the patientinterface structure 6000. The tab 6144 includes an enlarged end 6146that passes through the aperture 6142 and acts to prevent removal of theconnector 6138 once the enlarged end 6146 is passed through the aperture6142. The connector 6138 and the tab 6144 may be formed of flexiblematerial to allow the connector 6138 to be removed from the tab past theenlarged end 6146. The connector 6148 may be formed by, for example, diecutting to reduce the expense of forming the connector 6138. Theconnectors 6138 may thus be disposable and replaced, for example on aweekly basis. Referring to FIG. 118, the hook fastener 6140 may be gluedto the connector 6138.

3.3.2 Positioning and Stabilizing—Headgear Tabs Second Embodiment

Referring to FIGS. 119-121, the connectors 6152 may include a slot 6154.A strap 6156 which may comprise hook fasteners is threaded through theslot 6154 and may be ultrasonically welded, as shown by the arrows inFIG. 121, to connect the strap to the connector 6152.

3.3.3 Positioning and Stabilizing—Headgear Tabs Third Embodiment

Referring to FIG. 122, the tab 6162 of the patient interface structuremay be connected to a connector 6158 by a junction 6160.

3.3.4 Positioning and Stabilizing—Headgear Tabs Fourth Embodiment

Referring to FIGS. 123 and 124, the tab 6164 includes a folded portion6168 that folds over a strip 6166. An end portion 6172 of the tab 6164is secured to the tab 6164. The tab 6164 also includes an aperture 6170that is configured to connect the tab 6164 to the patient interfacestructure.

3.3.5 Positioning and Stabilizing—Headgear Tabs Fifth Embodiment

As shown in FIG. 125, the patient interface structure 6000 includes atab 6174 that includes a slot 6180. A connector 6176, that may includehook fasteners, includes an end portion 6178 that is passed through theslot 6180 and folded back on to the connector 6176 and attached thereto.

3.3.6 Positioning and Stabilizing—Headgear Tabs Sixth Embodiment

Referring to FIG. 126, according to a variation, the tab 6186 comprisestwo slots 6188 and an end portion 6184 of a connector 6182 is threadedthrough the two slots 6188 to secure the end portion 6184 to theconnector 6182.

3.3.7 Positioning and Stabilizing—Headgear Tabs Seventh Embodiment

Referring to FIG. 127, the patient interface structure 6000 includestabs 6192 having enlarged end portions 6194. The enlarged end portions6194 pass through apertures in connectors 6190 to secure the patientinterface structure 6000 to the connector or patient interfacepositioning and stabilizing structure 6190.

3.3.8 Positioning and Stabilizing—Headgear Tabs Eighth Embodiment

Referring to FIGS. 128 and 129, connectors 6196 may comprise apertures6198 to engage tabs of a patient interface structure. The apertures 6198include slots 6200 that assist in inserting the enlarged end portion6194 of the tabs of the patient interface structure 6000 through theapertures 6198.

3.3.9 Positioning and Stabilizing—Headgear Tabs Ninth Embodiment

Referring to FIG. 130, the tab 6206 comprises a slot 6208. The connector6202 is connected to a loop 6204 that is provided through the slot 6208.

3.3.10 Positioning and Stabilizing—Headgear Tabs Tenth Embodiment

Referring to FIGS. 131 and 132, a tab 6210 is configured to support apatient interface structure. The tab 6210 comprises an aperture 6212that corresponds to the aperture of the patient interface structure. Theaperture 6212 is configured to receive an elbow or a sealing ringconnected to a tube for delivery of the flow of breathable gas. The tab6210 comprises connector portions 6214 that are configured to beconnected to a patient interface positioning and stabilizing structure,for example an adhesive strip comprising fastener material such as loopfasteners, or to a headgear.

3.3.11 Positioning and Stabilizing—Headgear Tabs Eleventh Embodiment

As shown in FIG. 133, the tab 6216 may comprise an aperture 6218 forreceiving a sealing ring or an elbow connected to a tube to deliver aflow of breathable gas. Additional aperture 6220 may be provided forreceiving the ends of connectors or a patient interface stabilizing andpositioning structure having connectors insertable into the aperture6220.

It should be appreciated that the tabs shown in FIGS. 131-133 may beformed by die cutting.

3.3.12 Positioning and Stabilizing—Headgear Tabs Twelfth Embodiment

Referring to FIG. 134, a tab 6224 may be formed by molding the tab 6224on an elbow 6222 that is configured to be connected to a tube fordelivering a flow of breathable gas. The tab 6224 may comprise endportions 6226 that are configured to be connected to a patient interfacepositioning and stabilizing structure, such as an adhesive stripattached to the patient's nose that includes fastener material, or to aheadgear.

3.4 Positioning and Stabilizing—Elbow and Swivel 3.4.1 Positioning andStabilizing—Elbow and Swivel First Embodiment

Referring to FIGS. 111 and 112, a patient interface system according toanother sample embodiment includes an elbow 6006 that includes an angledportion 6006 a that is connected to the patient interface structure6000. The angled portion 6006 a of the elbow 6006 positions the tube2008 so that it extends straight down from the face of the patient andavoids the patient's chin. As shown in FIGS. 111 and 112, the elbow 6006is fixed with respect to the cushion 6000 and does not rotate. The elbow6006 may include a diffuser vent 6011. The tube 2008 is connected to theelbow 6006 through a swivel 6130 that permits the tube 2008 to swivel360° with respect to the elbow 6006.

3.4.2 Positioning and Stabilizing—Elbow and Swivel Second Embodiment

As shown in FIGS. 113 and 114, according to another sample embodiment,the tube 2008 may be connected to the patient interface structure 6000by a gusset 6132. The gusset 6132 is expandable as shown by the arrow toreduce tube drag. A swivel 6134 may be provided between the gusset 6132and the tube 2008 to allow the tube 2008 to swivel with respect to thepatient interface structure 6000.

The patient interface structure 6000 may include a vent 6133 that isintegrally formed with the patient interface structure 6000. It shouldbe appreciated that the vent 6133 may be provided as a separate partthat is attached to the patient interface structure 6000.

3.4.3 Positioning and Stabilizing—Elbow and Swivel Third Embodiment

Referring to FIGS. 115 and 116, the patient interface structure 6000 maybe connected to the tube 2008 by an elbow 6136. The elbow 6136 is notround and is attached to the patient interface structure 6000. The elbow6136 includes a vent 6139 that is easier to form than a vent formed inthe patient interface structure 6000. A swivel 6137 may be providedbetween the elbow 6136 and the tube 2008. The swivel 6137 may be moldedin a cuff of the tube 2008.

4.1 Patient Interface with Inflatable Pillows First Embodiment

Referring to FIGS. 71 and 72, a patient interface system 5000 comprisesa patient interface support structure 5010 that includes a tubeconnection portion 5020 that is configured to be connected to an airdelivery hose, tube or conduit. The patient interface support structure5010 comprises two openings 5040 that are configured to receive nasalpillows 5030 that are configured to be inserted into, and removablefrom, the openings 5040. As shown in FIG. 71, each nasal pillow 5030comprises a bellows 5050. When a flow of breathable gas is introducedinto the interface support structure 5010 from a hose, tube or conduit,the pressure created in the patient interface support structure 5010inflates each pillow 5030 inserted into each of the patient's nares. Thepillows 5030 seal against the interior walls of the patient's nares. Asthe pillows 5030 are removable from the openings of the patientinterface structure 5010, the pillows 5030 may be removed, for example,for cleaning, or for disposal.

The patient interface structure 5010 may include a support 5070 that isconfigured to engage the bridge of the patient's nose to support thepatient interface system 5000 in sealing engagement with the patient'snares. The support 5070 may be connected to the patient interfacesupport structure 5010 by a connecting member 5060.

4.2 Patient Interface with Inflatable Pillows Second Embodiment

Referring to FIG. 73, another sample embodiment of a nasal pillow 5100usable with the patient interface support structure 5010 comprises abase portion 5110 that is receivable in the opening 5040 of the patientinterface support structure 5010 and a sealing portion 5120 that isinsertable into the nare of the patient. The sealing portion 5120 mayexpand from the pressure created in the patient interface supportstructure 5010 when a flow of breathable gas is introduced therein. Thesealing portion 5120 may also include a textured outer surface toimprove the sealing against the interior of the patient's nares and/orimprove the wearing comfort of the pillows towards the nasal septum.

4.3 Patient Interface with Inflatable Pillows Third Embodiment

Referring to FIG. 74, another sample embodiment of a nasal pillow 5200usable with the patient interface support structure 5010 comprises abase portion 5210 that is receivable in the opening 5040 of the patientinterface support structure 5010. Each pillow 5200 comprises sealingportions 5220 that are insertable into the nare of the patient and thatexpand from pressure created in the patient interface support structure5010 when a flow of breathable gas is introduced therein. The sealingportions 5220 may comprise bellows to assist in expanding the sealingportions 5220 upon application of the pressure. The sealing portions5220 expand and seal against the interior of the patient's nares uponthe application of the pressure.

The support 5070 and the connecting member 5060 may be integrally formedwith the patient interface support structure 5010, for example as shownin FIG. 71. In another sample embodiment, shown in FIGS. 75 and 76, thesupport 5070 and the connecting member 5060 may be formed separately.The support 5070 may be, for example, secured to the bridge of thepatient's nose by adhesive. The connecting member 5060 may include slots5090 configured to receive straps configured to hold the patientinterface system 5000 in sealing engagement with the patient.

As shown in FIG. 75, an upper lip support 5080 may also be provided tosupport the patient interface support structure 5010. The upper lipsupport 5080 may be, for example, connected to the patient interfacesupport structure 5010 and/or the patient's upper lip by adhesive.

4.4 Patient Interface with Inflatable Pillows Fourth Embodiment

Referring to FIG. 77, a patient interface system 5000 according toanother sample embodiment includes a patient interface support structure5010 that includes a connection portion 5020 configured to be connectedto a hose, tube or conduit that delivers a flow of breathable gas. Anupper lip support 5080 may be provided to support the patient interfacesupport structure 5010 against the patient's upper lip. An inflatablemembrane 5300 is connected to the patient interface support structure5010 and is configured to be inflated when pressure is created by a flowof breathable gas into the patient interface support structure 5010. Theinflatable membrane 5300 may be formed, for example, of elasticmaterial. The inflatable membrane 5300 is connected to a pair of nasalpillows 5020 that each includes a bellows 5050 that is inflatable uponinflation of the inflatable membrane 5300.

A flexible membrane support 5430 is connected to the flexible membrane5300 by connectors 5400, 5410. A stop 5420 may be provided to theflexible membrane support 5430 to prevent the flexible membrane 5300from being overinflated.

The patient interface system 5000 may comprise the support 5070 and thesupport 5070 may be connected to the flexible membrane support 5430 by aconnecting member (not shown), such as shown in FIG. 76, for example.The connecting member may comprise slots configured to receive strapsfor supporting the patient interface system 5000 in sealing engagementwith the patient's nares.

The nose may act as a bearing for the inflated membrane 5300. Thecontact pressure for inflating the membrane 5300 and sealing the pillows5020 is adjusted by the therapy pressure and not by the mounting systemof the patient interface at the patient's head. The inflatable membrane5300 is mounted to the bellows 5050 which keep the membrane 5300 inposition and movements of the remaining patient interface system, e.g.the patient interface support structure, are offset. The combination ofthe elastic membrane and the bellows 5050 enables freedom of movement ofthe patient interface support structure 5010, for example movementcaused by tube drag, before leakage occurs.

5.0 Leak Guards

As shown in FIG. 67, the lateral strip 2176 may comprise an outer strip2184 and an adhesive strip 2188 configured to be adhered to the patient,e.g. across the nasal bridge. A dilation strip 2186 may be providedbetween the strips 2184, 2188.

Referring to FIGS. 68-70, leak guards may be provided to the face of thepatient 1. As shown in FIG. 68, a leak guard 2054 may be secured acrossthe bridge of the nose of the patient. As shown in FIG. 69, leak guards2056 may be provided at the creases between the sides of the nose of thepatient and the patient's cheeks. As shown in FIG. 70, a leak guard 2058may be provided across the upper lip of the patient. Such a leak guard2058 may be used, for example, to eliminate leaks potentially caused bypatients with mustaches.

The leak guards shown in FIGS. 68-70 may be foam-backed strips that areadhesively attached to the face of the patient. Alternatively, the leakguards may be mechanically secured to the face of the patient, forexample by securement to a cushion or mask.

6.0 Adhesive Properties

In the sample embodiments discussed above, the adhesive can be connectedto the interface in such a way that the patient interface structure andadhesive may be simultaneously removed and replaced. The swivel ring canbe permanently fixed to the adhesive tape, air delivery tube or patientinterface structure. The patient interface structure may be fixed to theadhesive tape.

The adhesive and interface should not leave visible signs of CPAP usefollowing treatment, for example pressure sores or messed up hair. Thiswill increase patient comfort and compliance with treatment. Theadhesive also should not leave a residue on the patient's face. However,if a residue does remain, it should be easily removed, for example by awet cloth or alcohol swab.

The adhesive and interface may be durable. Alternatively, the adhesiveand/or interface may be disposable. There may also be an ‘end of life’indicator on the adhesive and/or interface to alert the patient tochange their adhesive and/or interface or part thereof. This is toimprove hygiene and interface function.

The adhesive may be formed in strips that are, for example, generallyrectangular. Such strips may be aligned on the patient's face inpositions (vectors) that are sufficient to locate or locate and seal theinterface to the nares and/or mouth of the patient. Alternatively, thestrips may be triangular, circular or any other desired shape. Inanother form, an adhesive fitting guide may be provided with theinterface, for example alignment markings on the adhesive, drawings anddescriptions of correctly aligned interfaces.

The adhesive and interface should be able to function with about 2 cmH₂O-30 cmH₂O pressure applied from a flow generator. In another form,the adhesive and interface should be able to function with about 4 cmH₂O-12 cm H₂O pressure applied from a flow generator. It should beappreciated that these pressures are for use of the interface with aCPAP apparatus, i.e. an apparatus in which the interface sealinglyengages the patient's airways. Other pressure ranges may be possiblewith different apparatus, e.g. an apparatus in which the interface doesnot sealingly engage the patient's airways.

In one form, the adhesive may have a high tensile strength.

The tensile strength of the adhesive may be related to the size of theadhesive strip. The adhesive may have a higher tensile strength onsmaller adhesive strips and may have a lower tensile strength on largeradhesive strips.

The adhesive may also be flexible. This allows the adhesive to conformto multiple areas of the face, for example cheeks and/or nose.

The adhesive may be able to endure the different environmentalconditions found across the world, for example, humidity, temperature,and wind chill.

The adhesive may be no more than about 10 mm thick.

Preferably, the adhesive may remain sticky during the patient's sleep,for example, 4 hours, 8 hours, 12 hours.

The adhesive may be biocompatible. In another form, the adhesive may bebiodegradable.

The adhesive may be zinc oxide based, synthetic rubber (e.g.hydrocolloid), acrylic, silicone gel, polyurethane, hydrocolloid, etc.

The adhesive may be clear. Alternatively, the adhesive may be neutral orskin toned. Alternatively, the adhesive may be any color. In anotherform, the color of the adhesive may be used as an ‘end of life’indicator, e.g. fade to white when it needs to be disposed of.

The adhesive strips, hook and loop fastener material, and any othermaterial used in the interface system may be transparent, neutral orskin toned to be as unobtrusive as possible. The adhesive strips, hookand loop fastener material or any other material may be colored orpatterned to suit various users. For example, pink may be provided forfemale users.

The adhesive may be covered after use with a non-adhesive strip, orrelease paper. The adhesive may be covered after multiple uses with thenon-adhesive strip. For example, the adhesive may be re-covered at least5 times without losing integrity. Additionally, the non-adhesive stripmay be used to package and store the adhesive for long periods. Theadhesive should not deteriorate while in storage.

The adhesive on the strip may not cover the entire surface of theadhesive strip. For example, the adhesive may selectively be applied tothe adhesive strip to enable easier peel from the patient's face, betterperformance of the adhesive strip in shear, and/or to rest certain areasof the patient's skin with repeated use. For example, the adhesive maybe applied in horizontal lines across the adhesive strip (when viewed inits in use orientation) so that the strip may perform better in shearand/or be easier to remove from the patient's skin when peeledlaterally.

The interface should allow for venting. In another form, the adhesivemay allow some/all venting to occur. For example, a vent hole(s) may beprovided on the adhesive proximal to the interface to allow the passageof expired air from the patient.

The adhesive strips may have a non-sticky end. The non-sticky end willenable the user to easily remove the adhesive once applied. It alsomeans that should the interface need to be removed quickly; it can bedone so simply and intuitively. Alternatively, another form of a safetydisconnect feature may be included with the interface, for exampleperforations between the adhesive and patient interface structure.

The adhesive and interface may be coupled with a chest strap. The cheststrap may be releasably connected to the air delivery tube. The purposeof the chest strap is to provide more stability of the interface bypreventing the air delivery tube from a wide range of movement. Suchchest straps have been disclosed in U.S. Patent Application Publication2009/0078259 A1, the entire contents of which is incorporated herein byreference.

The adhesive may be able to be sterilized.

The adhesive used to stick the fastener or loop material to thepatient's face, e.g. the nose, may be a light switching adhesive. Lightswitching adhesives are sticky in the dark and when exposed to light,the stickiness deactivates/breaks down such that the strip would comeoff the nose more easily after exposure to light, for example after thepatient wakes up and turns on the light or exposes the adhesive strip tosunlight. This is desirable for sleeping as the patient's bedroom may bedark while the patient sleeps and the strip will be adhered to the nose.When the patient wakes up and opens their curtains or turns on a light,the strip would come off more easily. Such light switching adhesives maybe available from Lumina Adhesives of Göteburg, Sweden.

The adhesive may be an adhesive silicone gel. In addition to use on thepatient interface structure and/or the connectors, the adhesive siliconegel may be used as an accessory for a masked designed for elderlypatients, for example to promote healing of scars caused by ill fittingmasks. The adhesive silicone gel may also be used with other components,for example cheek supports and/or forehead supports. The mineral oilused in adhesive silicone gels may also be provided in the patientinterface structure and/or connectors and/or the patient interfacepositioning and stabilizing structure to enhance wound care and promoteskin healing. Alternatively, or in addition to, aloe vera may be used inthe patient interface structure and/or connectors and/or the patientinterface positioning and stabilizing structure.

Adhesive silicone gel as described above is available as Cica-Care™,available from Smith & Nephew. The adhesive silicone gel may beprovided, for example, on adhesive strips as described herein. Theadhesive silicone gel may soften, flatten and/or fade red, dark and/orraised scars, and relieve itching and discomfort. Cica-Care™ isavailable as an adhesive silicone contained within a gel sheet. Researchsuggests that the adhesive silicone in the gel sheet occludes the skinto hydrate a scar area. Moisture is locked into the skin around thescar, reducing the blood supply and deposit of collagen, which is whatthe body uses to rebuild wounded skin. The adhesive silicone gel acts tomake scar tissue paler in color, closer to the patient's natural skincolor.

Other adhesives suitable for use with the sample embodiments describedherein include zinc oxide adhesive, ultra-thin hydrocolloid (HDx) andSkinz Tape™. Skinz Tape™ may be used for neonatal care and adheres toskin and silicone. Such adhesives may be obtained from Kree TechInternational Corporation Inc. of Quebec.

Scapa North America of Windsor, Conn. provides silicone gel adhesive,BioFlex™ adhesives, and acrylic adhesives that may be used with thesample embodiments disclosed herein.

Acrylic, porous, and electrically conductive adhesives, available fromAdhesive Research of Glen Rock, Pa., may also be used with sampleembodiments disclosed herein. Dissolvable films available from AdhesivesResearch are also usable with sample embodiments disclosed herein.

The adhesives used with sample embodiments disclosed herein may also beacrylic adhesives and/or synthetic rubber adhesives available from, forexample, MACtac of Stow, Ohio, e.g. MACtac TM8410.

Light switching, pressure sensitive acrylic adhesive may also be usedwith sample embodiments disclosed herein. Such adhesives are availablefrom, for example, Lumina Adhesives of Goteborg, Sweden.

The adhesive strips described above placed over the bridge of thepatient's nose may have perforated portions, for example in the regionspositioned under the eyes and/or around the nose. The perforatedportions may be easily torn off the adhesive strip to allow the patientto customize the shape of the adhesive strip to suit the patient'sfacial profile.

The adhesive may also be porous such that the adhesive itself is moreflexible and conforming and allow the skin underneath the adhesive stripto move more readily. The adhesive may also be breathable. The adhesivemay also be coated on a stretchable backing fabric that allows the skinto move more freely. The adhesive and/or the backing fabric may have awarming effect to relieve any jetting sensation from the flow ofbreathable gas.

The adhesive strip or patch may have an area in the range of 250 mm² to300 mm², preferably 500 mm² to 2500 mm², more preferably 1,000 mm² to1,500 mm².

It should be appreciated that the patient interface structures disclosedabove need not be limited to providing CPAP therapy, but may include anydevice that is attached to the nose under conditions where pressure onthe face or back of the patient's head is not possible or advisable, forexample for use with burn victims.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.Furthermore, each individual component of any given assembly, one ormore portions of an individual component of any given assembly, andvarious combinations of components from one or more embodiments mayinclude one or more ornamental design features. In addition, while theinvention has particular application to patients who suffer from OSA, itis to be appreciated that patients who suffer from other illnesses(e.g., congestive heart failure, diabetes, morbid obesity, stroke,barriatric surgery, etc.) can derive benefit from the above teachings.Moreover, the above teachings have applicability with patients andnon-patients alike in non-medical applications.

What is claimed is:
 1. A patient interface system for delivering a flowof breathable gas to a patient, comprising: a patient interfacestructure configured to sealingly engage the patient's nares; a pair ofstrips configured to be connected to opposite sides of the patientinterface structure; and adhesive configured to secure the patientinterface structure in sealing engagement with the patient's nares,wherein the adhesive is provided on the strips, and the strips areconfigured to be adhered to sides of the patient's nose by the adhesive.2. A patient interface system according to claim 1, wherein the patientinterface structure is connected to the strips by a second adhesive. 3.A patient interface system according to claim 1, wherein the strips aregenerally rectangular, triangular, or circular.
 4. A patient interfacesystem according to claim 1, wherein at least one of the stripscomprises at least one hole and the patient interface structurecomprises at least one tab configured to be inserted into the at leastone hole.
 5. A patient interface system according to claim 4, whereinthe at least one hole comprises a plurality of holes.
 6. A patientinterface system according to claim 5, wherein the plurality of holesare connected by a channel.
 7. A patient interface system according toclaim 1, wherein the at least one adhesive strip comprise a locking tabconfigured to engage a loop connected to the patient interfacestructure.
 8. A patient interface system according to claim 7, whereinthe loop is integrally formed with the patient interface structure.
 9. Apatient interface system according to claim 7, further comprising asealing ring, wherein the sealing ring comprises the loop.
 10. A patientinterface system according to claim 1, wherein at least one of thestrips is covered by a release paper.
 11. A patient interface systemaccording to claim 1, wherein at least one of the strips comprises abottom portion configured to engage the patient interface structure anda top portion configured to engage the patient's nose.
 12. A patientinterface system according to claim 11, wherein the at least one of thestrips comprises an adhesive free portion between the top portion andthe bottom portion.
 13. A patient interface system according to claim11, wherein the at least one of the strips comprises at least onereinforcing element.
 14. A patient interface system according to claim13, wherein the at least one reinforcing element comprises a plastic ormetal strip.
 15. A patient interface system patient interface accordingto claim 1, wherein the adhesive comprises two adhesives.
 16. A patientinterface system according to claim 15, wherein one of the two adhesivescomprises synthetic rubber.
 17. A patient interface system according toclaim 15, wherein the two adhesives comprise double sided adhesives. 18.A patient interface system according to claim 17, further comprising anintermediate layer between the first and second adhesives.
 19. A patientinterface system according to claim 18, wherein the intermediate layeris impermeable.
 20. A patient interface system according to claim 1,wherein the patient interface structure comprises a pair of nasalpillows or prongs.